Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices 37401

assessment. Regulatory issues related to

standards and product quality and the

impact of the Food and Drug

Administration Modernization Act

(FDAMA) will also be addressed. The

Forum will feature plenary lectures and

focused discussion groups that include

FDA, industry, and university leaders in

the field, on the following topics: (1)

‘‘Biofarming and biopharming’’

(bioengineered plants and animals as

sources of foods and drugs); (2)

diagnostics and detection methods; (3)

microbial pathogens, antibiotics, and

resistance; (4) therapeutic and

preventive agents: Novel therapies, gene

therapy, cell and tissue engineering, and

vaccines; (5) new models/methods for

safety and efficacy assessment; and (6)

regulatory challenges: Standards,

product quality, FDAMA and impact on

biotechnology regulation, and public

acceptance of novel products.

The meeting is co-sponsored by FDA,

the American Association of

Pharmaceutical Scientists, and the FDA

Chapter of Sigma Xi, the Scientific

Research Society.

Dated: June 30, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18399 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0495]

Prescription Drug User Fee Act,

‘‘PDUFA II Five-Year Plan;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of an internal planning

document entitled ‘‘PDUFA II Five-Year

Plan.’’ This plan is intended to show

FDA’s anticipated prescription drug

user fee revenues and planned

expenditures of the fee revenues over

the 5-year period from 1998 through

2002. The plan is designed to assist in

achieving the new goals for the drug

review process under the Prescription

Drug User Fee Act of 1992 (PDUFA),

which was amended and extended

through the year 2002 by the Food and

Drug Administration Modernization Act

of 1997 (FDAMA). The amended and

extended PDUFA is referred to as

PDUFA II.

DATES: Written comments my be

provided at any time and will be

considered as the agency makes annual

adjustments to the plan in the second

quarter of each fiscal year.

ADDRESSES: Copies of this document are

available on the Internet at

‘‘www.fda.gov/oc/pdufa2/

5yrplan.html’’. For those without

Internet access, single copies of this

plan may be obtained from the Division

of Management Systems and Policy

(HFA–300), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Please send a selfaddressed adhesive label to assist that

office in processing your request.

Submit written comments on the plan to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Frank P. Claunts, Division of

Management Systems and Policy (HFA–

300), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–5501.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of an

internal planning document entitled

‘‘PDUFA II Five-Year Plan.’’ PDUFA

was amended and extended through the

year 2002 by FDAMA. The amended

and extended PDUFA is referred to as

PDUFA II. PDUFA II authorizes

appropriations and fees that will

provide FDA with resources to sustain

the drug review staff developed in the

last 5 years and to achieve the even

more stringent new goals.

The plan begins with a statement of

purpose, provides background

information on PDUFA and a summary

of the new goals, and discusses the 10

major assumptions on which the plan is

based. Included is the assumption that

this plan is dynamic and will be

reassessed each fiscal year through

2002. The individual plans of agency

components with major PDUFA

responsibilities are summarized,

followed by a summary of associated

expenditures and an agency summary.

In our continuing efforts to maximize

the availability and clarity of

information about our review processes

and plans, we are sharing this plan with

all who have an interest and making it

available on the Internet. We welcome

comments and will consider them in the

future as annual adjustments are made

to the plan.

Interested persons, may at any time,

submit written comments to the Dockets

Management Branch (address above).

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The guidance document and

received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: July 3, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18401 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0512]

Draft ‘‘Guidance for Industry: For the

Submission of Chemistry,

Manufacturing and Controls and

Establishment Description Information

for Human Blood and Blood

Components Intended for Transfusion

or for Further Manufacture and For the

Completion of the FDA Form 356h,

Application to Market a New Drug,

Biologic or an Antibiotic Drug for

Human Use;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

document entitled ‘‘Guidance for

Industry: For the Submission of

Chemistry, Manufacturing and Controls

and Establishment Description

Information for Human Blood and Blood

Components Intended for Transfusion

or for Further Manufacture and For the

Completion of the FDA Form 356h,

Application to Market a New Drug,

Biologic or an Antibiotic Drug for

Human Use.’’ The draft guidance

document is intended to assist

applicants in the preparation of the

content and format of the chemistry,

manufacturing, and controls (CMC)

section and the establishment

description section of a biologics license

application (BLA), revised Form FDA

356h, for human blood and blood

components intended for transfusion or

for further manufacture. In addition, the

draft guidance document provides

assistance for the completion of the

BLA. This action is part of FDA’s

continuing effort to achieve the

objectives of the President’s

‘‘Reinventing Government’’ initiatives

and the Food and Drug Administration